BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 4212356 · Received October 30, 2014

    Report

    Report Number
    2939301-2014-29041
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 21, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (01/28/2015). THE PATIENT¿S METER HAS BEEN RETURNED ON 1/12/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/26/2015 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE RETAIN TEST STRIPS HAVE BEEN EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/9/2015 WITH THE FOLLOWING FINDINGS: THE RETAIN TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHEN THE RETURNED TEST STRIPS, WHEN TESTED WITH CONTROL SOLUTION, DO NOT FILL. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 01/16/2015 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT¿S ONETOUCH PING METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN IN (B)(6) 2014, EXACT DATE/TIME IS NOT KNOWN. THE PATIENT REPORTEDLY OBTAINED A VALUE OF ¿180 MG/DL¿ WITH THE SUBJECT METER WHICH THEY FELT WERE HIGH AS COMPARED TO HIS USUAL READINGS/FEELINGS. IT IS NOT KNOWN WHAT RANGE THE PATIENT CONSIDERS TO BE NORMAL. THE PATIENT MANAGES HIS DIABETES WITH AN UNKNOWN FIXED DOSE OF INSULIN. THE PATIENT REPORTEDLY INCREASED HIS DOSE OF INSULIN TO AN UNKNOWN AMOUNT IN RESPONSE TO THE ALLEGED ISSUE. AT AN UNKNOWN TIME AFTER THE ISSUE OCCURRED, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF ¿HYPOGLYCEMIA, SWEATY, NERVOUS AND VERY AGITATED.¿ IT IS NOT KNOWN IF THE PATIENT RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION. QUALITY CONTROL TESTING WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTEDLY OBTAINED AN INACCURATE HIGH BLOOD GLUCOSE READING ON THE SUBJECT METER, ADMINISTERED AN UNSPECIFIED AMOUNT OF INSULIN AND DEVELOPED SYMPTOMS OF HYPOGLYCEMIA AFTER OBTAINING HIGH READINGS ON THE SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695945 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3637287

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening